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FDA 510(k)

GM85

K-Number: K222353 · 2022-09-29

ApplicantSamsung Electronics Co., Ltd.
Decision Date2022-09-29
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GM85 is a medical device manufactured by Samsung Electronics Co., Ltd.. It received FDA 510(k) clearance on 2022-09-29 under approval number K222353. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GM85?

GM85 is a medical device that received FDA 510(k) clearance on 2022-09-29. It is manufactured by Samsung Electronics Co., Ltd.. The 510(k) number is K222353.

When was GM85 approved by the FDA?

GM85 received FDA 510(k) clearance on 2022-09-29, under approval number K222353.

What company makes GM85?

GM85 is manufactured by Samsung Electronics Co., Ltd..

What is the FDA product code for GM85?

The FDA product code for GM85 is IZL.

Other Devices by Samsung Electronics Co., Ltd.

K163115GC70 K162278Digital Diagnostic Mobile X-ray System K160997GC85A K172229GC85A K171119GM85 K182183GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A

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Related Devices (Code: IZL)

K163063UC-5000 Mobile X-RaySource-Ray, Inc. K162990Optima XR240amxGe Medical Systems, LLC K162278Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. K162687Paragon 2Meridian Medical Systems, LLC K161345RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIRSedecal., Sa. K153059HF1202H PowerPlus Portable X-ray EquipmentMinxray, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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